[Federal Register Volume 78, Number 82 (Monday, April 29, 2013)]
[Notices]
[Pages 25090-25091]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-10041]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection, 60-day Comment Request: Certificate of 
Confidentiality Electronic Application System

SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995, to provide the opportunity for 
public comment on proposed data collection projects, the Office of 
Extramural Research (OER) of the National Institutes of Health (NIH) is 
developing an electronic application form for the submission of 
requests to NIH for Certificates of Confidentiality (CoCs).
    Written comments and/or suggestions from the public and affected 
agencies are invited on one or more of the following points: (1) 
Whether the proposed collection of information is necessary for the 
proper performance of the function of the agency, including whether the 
information will have practical utility; (2) the accuracy of the 
agency's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on those who are to respond, including the 
use of appropriate automated, electronic, mechanical, or other 
technological collection techniques or other forms of information 
technology.
    To Submit Comments and For Further Information: To obtain a copy of 
the data collection plans and instruments, submit comments in writing, 
or request more information on the proposed project, contact: Dr. Ann 
M. Hardy, NIH Extramural Human Research Protections Officer and 
Coordinator, Certificates of Confidentiality, Office of Extramural 
Programs, OER, NIH, 3701 Rockledge Drive, Room 3002, Bethesda, MD 
20892; or call the non-toll-free number (301) 435-2690; or email your 
request, including your address, to [email protected]. Formal requests 
for additional plans and instruments must be requested in writing.
    Comment Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 60 days 
of the date of this publication.
    Proposed Collection: Certificate of Confidentiality Electronic 
Application System 0925-New, Office of Extramural Research (OER), 
National Institutes of Health (NIH).
    Need and Use of Information Collection: This application system 
will provide one electronic form to be used by all research 
organizations that wish to request a Certificate of Confidentiality 
(CoC) from NIH. As described in the authorizing legislation (Section 
301(d) of the Public Health Service Act, 42 U.S.C. 241(d)), CoCs are 
issued by the agencies of the Department of Health and Human Services 
(HHS), including NIH, to authorize researchers conducting sensitive 
research to protect the privacy of human research subjects by enabling 
them to refuse to release names and identifying characteristics of 
subjects to anyone not connected with the research. At the NIH, the 
issuance of CoCs has been delegated to the individual NIH Institutes 
and Centers (ICs). The NIH ICs collectively issue approximately 1,000 
new CoCs each year for eligible research projects. However, the process 
for submitting a CoC request is not consistent across the ICs, which 
creates confusion for applicants. To make the application process 
consistent across the entire agency, the OER is proposing to use an 
electronic application system that will be accessed by research 
organizations that wish to request a CoC from any NIH

[[Page 25091]]

IC. Having one system for all CoC applications to NIH will be efficient 
for both applicants and NIH staff who process these requests. As is 
currently done, the NIH will use the information in the application to 
determine eligibility for a CoC and to issue the CoC to the requesting 
organization.
    Office of Management and Budget approval is requested for 3 years. 
There are no costs to respondents other than their time. The total 
estimated annualized burden hours is 1,500.

                                        Estimated Annualized Burden Hours
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                                                                                   Average time
               Type of respondents                   Number of     Frequency of    per response    Total annual
                                                    respondents      response       (in hours)     burden hours
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CoC Applicants-.................................             400               1             1.5             600
Private.........................................
CoC Applicants-.................................             450               1             1.5             675
State/local.....................................
CoC Applicants-.................................              50               1             1.5              75
Small business..................................
CoC Applicants-.................................             100               1             1.5             150
Federal.........................................
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    Dated: April 22, 2013.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2013-10041 Filed 4-26-13; 8:45 am]
BILLING CODE 4140-01-P